CancerNCT03835052
QOL Assessment in Cancer Survivors Integrated Into Routine Clinical Care
An observational study of Cancer, run by Geisinger Clinic at 1 site in United States.
Trial summary
This observational cohort study of patients who received cancer treatment (of any modality) in the last 18 months are evaluated by the use of a validated QOL tool (FACT-GP) and are evaluated via telephone or in person or both. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cancer
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 30 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients meeting criteria identified through the use of analytics querying the central data architecture of health system
Who may be able to join
- Diagnosis of malignancy in the last 18 months, treated with curative intent
Who cannot join
- Patients treated with palliative intent, metastatic disease at the time of diagnosis
Trial locations and contacts
1 site in 1 country.
United States1 site
Geisinger Medical Center
Danville, Pennsylvania, 17822
About this study
Official title: Quality of Life Assessment in Cancer Survivors Integrated Into Routine Clinical Care Implementation in an Integrated Health System
This observational cohort study of patients who received cancer treatment (of any modality) in the last 18 months are evaluated by the use of a validated QOL tool (FACT-GP) and are evaluated via telephone or in person or both. Patients with high-risk for unmet needs or distress as determined by the FACT-GP are referred to an in-person Multidisciplinary Cancer Survivorship Clinic. This is considered standard of care at the investigator's institution and is part of the continuous clinical quality improvement program within the Geisinger Cancer Institute.
- Conditions
- Cancer
- Keywords
- Survivorship
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Survivorship Care Plan (SCP) is completed and given to the patient
A completed Survivorship Care Plan (SCP) as defined by the American College of Surgeons, Committee on Cancer (ACS-CoC) is completed by a member of the clinical care team and is provided personally to the patient.
Measured: Within 12 months of date of diagnosis
Secondary outcomes (2)
Oncology Behavioral Health Referral Follow-up
FACT-GP v.4, Emotional Well-Being Sub-score (EWB) are referred to the Oncology Behavioral Health Service for an evaluation by a PhD behavioral health practitioner.
Measured: Within 30 days of administration of FACT-GP
Emergency Department utilization, 30 days after completion of SCP
Percentage of patients who present to an Emergency Department as captured in central clinical data architecture
Measured: Within 30 days of receipt of Supportive Care Plan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2019
- Study start1 Oct 2018
- Primary completion25 Mar 2020
- Study completion30 Mar 2020
Why it stopped: COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geisinger Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian S. Adonizio, MD, Geisinger Clinic
- Investigators
- Christian S Adonizio, MD, Study chair, Geisinger Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03835052
- Sponsor's protocol ID
- 2018-0568
- Status last verified
- Mar 2021
- First submitted
- 6 Feb 2019
- Last updated
- 2 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life Assessment in Cancer Survivors Integrated Into Routine Clinical Care Implementation in an Integrated Health System
- ClinicalTrials.gov ID
- NCT03835052
- Acronym / sponsor ID
- 2018-0568
- Conditions
- Cancer
- Keywords
- Survivorship
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: COVID-19
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Geisinger ClinicUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 25 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 8 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This observational cohort study of patients who received cancer treatment (of any modality) in the last 18 months are evaluated by the use of a validated QOL tool (FACT-GP) and are evaluated via telephone or in person or both. Patients with high-risk for unmet needs or distress as determined by the FACT-GP are referred to an in-person Multidisciplinary Cancer Survivorship Clinic. This is considered standard of care at the investigator's institution and is part of the continuous clinical quality improvement program within the Geisinger Cancer Institute.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients meeting criteria identified through the use of analytics querying the central data architecture of health system
Key inclusion criteria (1 listed)
- Diagnosis of malignancy in the last 18 months, treated with curative intent
Key exclusion criteria (1 listed)
- Patients treated with palliative intent, metastatic disease at the time of diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Survivorship Care Plan (SCP) is completed and given to the patient
Time frame: Within 12 months of date of diagnosis
A completed Survivorship Care Plan (SCP) as defined by the American College of Surgeons, Committee on Cancer (ACS-CoC) is completed by a member of the clinical care team and is provided personally to the patient.
2 secondary outcomes
Oncology Behavioral Health Referral Follow-up
Time frame: Within 30 days of administration of FACT-GP
Emergency Department utilization, 30 days after completion of SCP
Time frame: Within 30 days of receipt of Supportive Care Plan
Results and safety
The study was stopped early (reason given: COVID-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian S Adonizio, MD study chair
Geisinger Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Geisinger Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: COVID-19). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survivorship Care Plan (SCP) is completed and given to the patient (time frame: Within 12 months of date of diagnosis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2021.